FDA device listing
CoverSeal-D, Mounting Media,CoverSeal-Plus, Mounting Media,CoverSeal-T, Mounting Media,CoverSeal-X, Mounting Media,DPX…
FDA device listing 2018635120 · Cancer Diagnostics, Inc.
Key facts
| Proprietary names | CoverSeal-D, Mounting Media,CoverSeal-Plus, Mounting Media,CoverSeal-T, Mounting Media,CoverSeal-X, Mounting Media,DPX Mounting Medium,Refrax Mounting Medium |
|---|---|
| Owner/operator | Cancer Diagnostics, Inc. |
| Owner/operator number | 10027057 |
| Product codes | LEB |
| Device names | LEB - Mounting Media |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | ANATECH division of Cancer Diagnostics, Inc., Cancer Diagnostics, Inc. |
| Establishment registrations | 1831338, 3007496191 |
| FEI numbers | 1831338, 3007496191 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database